CT Volumetry and Hepatic Vascular Deformation Mapping to Predict Post-Hepatectomy Liver Failure

NCT07727759 | Recruiting DMC

• 1 other identifier: 2059:7/2026
• Study Type: observational
• Target: 1,070
• Locations: 1 country
• Sites: 3

Brief Summary

Removing a large part of the liver (major hepatectomy) can cure primary and secondary liver cancers, but it carries the risk of post-hepatectomy liver failure (PHLF), a serious complication in which the liver left behind - the future liver remnant (FLR) - cannot meet the body's metabolic needs. PHLF occurs after roughly 5% to 15% of major hepatectomies and is the leading cause of postoperative death. Before surgery, surgeons routinely use CT scans to measure how much liver will remain (CT volumetry). Volume alone does not tell the whole story. After a large resection the remaining liver can rotate and shift into the empty space left behind, kinking or compressing the veins that drain it. The resulting congestion can make an apparently adequate remnant fail. This prospective, multicenter, observational cohort study tests whether adding two elements to standard CT volumetry improves the preoperative prediction of liver failure:

1. 1.Hepatic vascular deformation mapping (VDM), a three-dimensional image-analysis technique that quantifies the geometry and displacement of the hepatic veins and the portal vein; and
2. 2.A set of simple, reproducible measurements that any radiologist can make on a standard CT scan (hepatic vein diameters, congestion index, spleen volume, liver attenuation, and the distances from the veins to the planned resection plane).

Conditions

Liver Failure; Liver Metastases; Hepatic Congestion; Post-Hepatectomy Liver Failure; Postoperative Complications; Liver Neoplasms; Carcinoma, Hepatocellular

Keywords

post-hepatectomy liver failure; CT volumetry; future liver remnant; vascular deformation mapping; hepatic venous congestion; major hepatectomy; clinical prediction model; ISGLS criteria; congestion index; hepatobiliary surgery; risk stratification

Outcome Measures

Primary Outcomes (1)

• Change in discrimination (delta AUC-ROC) for preoperative prediction of post-hepatectomy liver failure: CT volumetry plus vascular deformation mapping (Model 2) minus CT volumetry alone (Model 1)

  One value is reported: delta AUC-ROC = AUC-ROC (Model 2) minus AUC-ROC (Model 1), with a 95% confidence interval. Unit of measure: AUC units (dimensionless). AUC-ROC ranges from 0.5 (no discrimination) to 1.0 (perfect discrimination); delta AUC-ROC therefore ranges from -0.5 to +0.5, and a positive value indicates that vascular deformation mapping improves prediction. Measurement tool: two nested mixed-effects logistic regression models, each with center as a random intercept, fitted in the same participants. Model 1 (volumetry) = total liver volume, future liver remnant (FLR) volume, FLR ratio, FLR-to-body-weight ratio, resection volume. Model 2 = Model 1 plus vascular deformation mapping parameters (right, middle and left hepatic vein angle to the IVC, hepatic vein confluence-to-IVC-ostium distance, vascular displacement index, portal vein angulation). Post-hepatectomy liver failure (PHLF) is defined and centrally adjudicated as specified in Outcome Measure 2.

  PHLF is ascertained in each participant from the day of resection to postoperative day 30; the two models are compared after the last enrolled participant completes 30-day follow-up (through study completion, up to 24 months)

Secondary Outcomes (7)

• Incidence of post-hepatectomy liver failure (PHLF)

  From the day of resection to postoperative day 30

• Discrimination (AUC-ROC) of the full model: CT volumetry plus VDM plus simple radiology parameters

  Through study completion (up to 24 months)

• Calibration of the final prediction model

  Through study completion (up to 24 months)

• Incidence of radiologic postoperative hepatic congestion

  From the day of resection to postoperative day 30

• Incidence of transient hepatic attenuation differences (THAD)

  From the day of resection to postoperative day 30

Study Arms (1)

Major hepatic resection cohort

Preoperative CT volumetry with hepatic vascular deformation mapping (VDM) Consecutive adults (18 years or older) undergoing elective major hepatic resection (three or more Couinaud segments) for benign or malignant liver disease at a participating tertiary hepatobiliary center, with a preoperative multiphasic contrast-enhanced CT of quality sufficient for central core-laboratory analysis. All participants receive standard-of-care surgical management. The exposures of interest are the preoperative imaging phenotypes - CT volumetry, hepatic vascular deformation mapping, and simple radiology parameters - derived centrally from the routinely acquired preoperative CT. Participants are classified after surgery according to whether or not they develop post-hepatectomy liver failure.

Diagnostic Test: Preoperative CT volumetry with hepatic vascular deformation mapping (VDM)

Interventions

Preoperative CT volumetry with hepatic vascular deformation mapping (VDM) DIAGNOSTIC_TEST

Central, non-invasive core-laboratory analysis of the multiphasic contrast-enhanced CT already acquired in routine preoperative work-up; no additional imaging is performed. Images are pseudonymized at source and sent through a secure de-identified pipeline. Using specialized 3D software and one standardized protocol, three sets are extracted: (1) volumetry - total liver volume, future liver remnant (FLR) volume, FLR ratio, FLR-to-body-weight ratio, resection volume; (2) hepatic vascular deformation mapping - hepatic vein angles to the IVC, confluence-to-ostium distance, vascular displacement index, portal vein angulation; and (3) simple radiology parameters on standard CT - hepatic vein, portal, aortic and IVC diameters, congestion index, spleen volume, liver and liver-to-spleen attenuation, remnant attenuation homogeneity, vein-to-resection-plane distances, remnant artery diameter, remnant perfusion index. At least 10% of studies per center are double-read for reliability.

Also known as: CT volumetry; Vascular deformation mapping; Central core-laboratory image analysis

Major hepatic resection cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Consecutive adult patients undergoing elective major hepatic resection (three or more Couinaud segments) for benign or malignant liver disease at participating tertiary hepatobiliary referral centers in Egypt. Each center enrolls consecutive eligible patients, in order to minimize selection bias, until the overall target sample size is reached.

You may qualify if:

• Age 18 years or older
• Scheduled to undergo major hepatic resection, defined as the removal of three or more Couinaud segments, at a participating center
• Availability of a preoperative multiphasic contrast-enhanced CT of the liver of quality sufficient for central core-laboratory analysis
• Willing and able to complete postoperative clinical and laboratory follow-up for at least 30 days
• Written informed consent

You may not qualify if:

• Minor hepatic resection (fewer than three Couinaud segments)
• Significant pre-existing vascular anomaly or vascular pathology (for example, portal vein thrombosis)
• Emergency hepatic resection for trauma
• Preoperative imaging that fails central quality control
• Incomplete follow-up data

Sponsors & Collaborators

• Minia University: lead
• National Liver Institute, Egypt: collaborator
• Maadi Armed Forces Medical Compound, Ministry of Defence: collaborator

Study Sites (3)

Liver and GIT Hospital, Faculty of Medicine, Minia University

Minya, Minya Governorate, 61519, Egypt

RECRUITING

Maadi Armed Forces Medical Compound - Department of Liver and Pancreas Surgery and Liver Transplantation

Maadi, Egypt

RECRUITING

National Liver Institute, Menoufia University

Shibīn al Kawm, Egypt

RECRUITING

Related Publications (6)

• Rahbari NN, Garden OJ, Padbury R, Brooke-Smith M, Crawford M, Adam R, Koch M, Makuuchi M, Dematteo RP, Christophi C, Banting S, Usatoff V, Nagino M, Maddern G, Hugh TJ, Vauthey JN, Greig P, Rees M, Yokoyama Y, Fan ST, Nimura Y, Figueras J, Capussotti L, Buchler MW, Weitz J. Posthepatectomy liver failure: a definition and grading by the International Study Group of Liver Surgery (ISGLS). Surgery. 2011 May;149(5):713-24. doi: 10.1016/j.surg.2010.10.001. Epub 2011 Jan 14.

  PMID: 21236455 BACKGROUND

• Vauthey JN, Chaoui A, Do KA, Bilimoria MM, Fenstermacher MJ, Charnsangavej C, Hicks M, Alsfasser G, Lauwers G, Hawkins IF, Caridi J. Standardized measurement of the future liver remnant prior to extended liver resection: methodology and clinical associations. Surgery. 2000 May;127(5):512-9. doi: 10.1067/msy.2000.105294.

  PMID: 10819059 BACKGROUND

• Kanno H, Yoshida A, Goto Y, Hisaka T, Akagi Y, Okuda K. A case of hepatic venous outflow obstruction caused by migration of the remnant liver into the subphrenic space after extended posterior sectionectomy of the liver. Int J Surg Case Rep. 2020;76:297-300. doi: 10.1016/j.ijscr.2020.09.203. Epub 2020 Oct 6.

  PMID: 33065490 BACKGROUND

• Moriyasu F, Nishida O, Ban N, Nakamura T, Sakai M, Miyake T, Uchino H. "Congestion index" of the portal vein. AJR Am J Roentgenol. 1986 Apr;146(4):735-9. doi: 10.2214/ajr.146.4.735.

  PMID: 3485345 BACKGROUND

• Kutaiba N, Chung W, Goodwin M, Testro A, Egan G, Lim R. The impact of hepatic and splenic volumetric assessment in imaging for chronic liver disease: a narrative review. Insights Imaging. 2024 Jun 18;15(1):146. doi: 10.1186/s13244-024-01727-3.

  PMID: 38886297 BACKGROUND

• Balzan S, Belghiti J, Farges O, Ogata S, Sauvanet A, Delefosse D, Durand F. The "50-50 criteria" on postoperative day 5: an accurate predictor of liver failure and death after hepatectomy. Ann Surg. 2005 Dec;242(6):824-8, discussion 828-9. doi: 10.1097/01.sla.0000189131.90876.9e.

  PMID: 16327492 BACKGROUND

MeSH Terms

Conditions

Liver Failure; Liver Neoplasms; Carcinoma, Hepatocellular; Postoperative Complications

Condition Hierarchy (Ancestors)

Hepatic Insufficiency; Liver Diseases; Digestive System Diseases; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Saleh K Saleh, MD

  Minia University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Saleh K Saleh, MD

CONTACT

01201765401; salehkhairy@mu.edu.eg

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: July 16, 2026
• First Posted: July 27, 2026
• Study Start: August 15, 2026
• Primary Completion (Estimated): April 30, 2028
• Study Completion (Estimated): July 31, 2028
• Last Updated: August 18, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (3)